Release Notes Version 2.1

Released July 12, 2009

Initiatives

IRB Merger

The system was updated to support the IRB Health Science and IRB Behavioral Science restructuring. More information...

Subject Fee Payment Initiative

Modifications have been made to support the new M-Pathways Subject Fee Payment initiative which will eventually be the system that processes subject fee payment requests. Study Teams that are paying their subjects will need to respond to one additional question on the human subjects application (13.3.1).

RM/PM system integration

Study teams will be able to associate their PAF entered in Proposal Management with their human subjects application in Regulatory Management. This is the first step in integrating the Regulatory Management and Proposal Management systems.

IBC Renewal Form

A renewal form and workflow has been added to IBC rDNA registrations.

Additional Changes

Application Form Changes

Conditional logic has been added to additional questions in the application

For follow-up reports that are initiated while the original AE is in progress, links to original AE will be available as soon as the original AE is approved

Amendment & SCR Form Changes

Section 2-3 Race and ethnicity tables have been removed and the question has been reworded

Data in 5.2.1, How many subjects are represented in the data or specimens to be analyzed?, will populate in the SCR

New section 4: Additional Supporting Documents

New question, 1.5, on Amendment cover sheet: If the amendment includes a revision to the informed consent document or process, specify which subjects, if any, you intend to re-consent [*Required for clinical interventions for which subjects have already been consented and all IRBMED studies]. If you will re-consent no subjects, provide rationale (e.g., no subjects at this site assigned to affected group) in the box below. If you will re-consent only certain subjects (e.g., those still undergoing study intervention/interactions, those in the experimental arm), enter the criteria and justification in the box below.

Letters & Notification Changes

Broken link in final outcome notices has been corrected

Exempt category will display on AME and letter

An approval letter template has been added for Umbrella applications

Text added to Not Regulated Case Studies Clinical letter:
If this case study is about a UMHS patient's healthcare, journals are now requiring authorization from the patients in order to publish. If the patient is deceased submit your application to the IRB (changing any questions regarding decedents that you may have mis-answered). If the patient is living the Patient Authorization form can be found on the IRBMED forms page at <update link>.

The MCRU letter template has been revised

CRBU notifications have been updated to capture cancer center submissions

PI & Study Team Process and Workspace Changes

New Help tab will display Help Desk and IRB office contact information

The approved submission snapshot will display on the Main tab

Completed amendment activity record will display on the Main tab

Review Committee Process & Workspace Changes

Reviewer checklist has a new question on the Submit Review page: Are you ready to submit your review? Y/N

Checklists have been updated to reflect changes to the submissions

Core Staff Process & Workspace Changes

Primary and Secondary reviewers can be assigned to Expedited submissions

Reviewers must submit their reviewer checklists in order for staff to issue a final approval

For HUD submissions, terminated letter will display and study will change to terminated